FDAClass IIJuly 27, 2016

10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl recall: Particulate Matter

10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code…

Why was 10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl recalled?

Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number 160460017C , Exp. Date 5/12/2016 ; Lot Number 160600019C , Exp. Date 5/26/2016 ; Lot Number 160670016C , Exp. Date 6/2/2016 ; Lot Number 160740027C , Exp. Date 6/9/2016 ; Lot Number 160810024C , Exp. Date 6/16/2016 ; Lot Number 160880005C , Exp. Date 6/23/2016 ; Lot Number 160950036M , Exp. Date 6/29/2016 ;

Product
10 mcg/mL Fentanyl Citrate and 0.075% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride, 100 mL in 100 mL Hospira LifeCare Bag, Service Code…
Recalling firm
Pharmedium Services, LLC
Quantity
750 bags
Distribution
Nationwide
Recall date
July 27, 2016
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls